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Total Knee ArthroplastyPhase 3OPRANCT01616836

Optimizing Pain and Rehabilitation After Knee Arthroplasty

A Phase 3 study testing continuous FNB, single femoral nerve block and local infiltration analgesia in people with Total Knee Arthroplasty, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to determine the best method of pain control that will help with rehabilitation after total knee arthroplasty (TKA). Currently, the best method for pain control after TKA appears to be continuous femoral nerve block (FNB) where a small tube is placed beside the nerve that provides sensation to… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Total Knee Arthroplasty
What is being tested?
continuous FNB, single femoral nerve block and local infiltration analgesia
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesCanada
Study dates
Sep 2012to Dec 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults undergoing primary, tri-compartmental knee arthroplasty

Who cannot join

  • Allergy, intolerance, or contraindication to any study medication
  • Inability to walk independently prior to TKA
  • Inability to comprehend French or English
  • Use of major tranquilizers
  • ASA 4 or 5
  • BMI > 40
  • Opioid tolerance (opioid consumption > 30mg oral morphine or equivalent per day)
  • Pregnancy

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

About this study

Official title: Optimizing Pain and Rehabilitation After Knee Arthroplasty - Randomized, Blinded Clinical Trial Comparing Continuous Femoral Nerve Block Versus Single Injection Femoral Nerve Block Versus Local Infiltration Analgesia

The aim of this study is to determine the best method of pain control that will help with rehabilitation after total knee arthroplasty (TKA). Currently, the best method for pain control after TKA appears to be continuous femoral nerve block (FNB) where a small tube is placed beside the nerve that provides sensation to a large part of the knee and local anesthetic infused after surgery causing numbness to the surgical site. A single injection method also exists and may provide similar benefits. Both methods require training and can result in side effects such as temporary weakness (while the local anesthetic is still working) that can inhibit rehabilitation. A newer method injecting local anesthetic into the joint after surgery (Local Infiltration Analgesia (LIA)) is becoming common, does not cause weakness and can be done quickly at the end of surgery. It is unknown if the pain control provided by LIA is as good as that of FNB. This study will compare the femoral nerve block, continuous femoral nerve block and LIA technique to determine which provides better pain relief after TKA.

Read the detailed description

This will be a prospective, randomized, double blind study. Patients will be randomized using a computer-generated sequence to one of three groups:

Group 1: Continuous femoral nerve block group (cFNB) Group 2: Single injection femoral nerve block group (sFNB) Group 3: Local infiltration analgesia group (LIA)

Inclusion criteria: Patients between the ages of 18 and 85 having primary tri-compartmental total knee arthroplasty.

Exclusion criteria: Allergy, intolerance, or contraindication to any study medication (see below), inability to walk independently prior to TKA, inability to comprehend French or English, use of major tranquilizers, ASA 4 or 5, BMI > 40, opioid tolerance (opioid consumption > 30mg oral morphine or equivalent per day), pregnancy

Being tested
continuous FNB, single femoral nerve block, local infiltration analgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • continuous FNBOther

    femoral nerve block (ropivacaine 0.5%, 20 mL) with femoral nerve block infusion 48 h (ropivacaine 0.2%, 5mL/h), placebo local infiltration

  • single femoral nerve blockOther

    single femoral nerve block (ropivacaine 0.5%, 20 mL), placebo femoral nerve block infusion, placebo local infiltration

  • local infiltration analgesiaOther

    placebo fascia iliac block, placebo fascia iliaca infusion, local infiltration analgesia (tricompartmental injection of 150 mL ropivacaine 0.2%, ketorolac 30 mg, epinephrine 10 microg/mL)

Study groups in NCT01616836
Study groupRoleWhat they receive
continuous FNBActive comparatorBolus femoral nerve block (ropivacaine 0.5% 20 mL), continuous infusion 48 hours (ropivacaine 0.2%, 5 mL/h), placebo local infiltration
Receives: Other: continuous FNB
single FNBActive comparatorfemoral nerve block (ropivacaine 0.5% 20 mL), placebo femoral nerve block infusion, placebo local infiltration
Receives: Other: single femoral nerve block
LIAActive comparatorplacebo fascia iliac block, placebo fascia iliaca infusion, local infiltration analgesia
Receives: Other: local infiltration analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Numeric Rating Scale for Pain

    Pain at this time is the primary impediment to beginning physiotherapy and achieving discharge criteria

    Measured: 09h00 on postoperative day 2

Secondary outcomes (11)

  1. Opioid consumption

    Opioid consumption is a surrogate outcome for pain. A reduction in opioid consumption also confers benefits of reduced side effects - nausea, dizziness, sedation, respiratory depression

    Measured: Cumulative 4 day consumption

  2. Knee range of motion

    Active and passive range of motion - physical outcome measure

    Measured: Measured each postoperative day (4 day maximum) during daily physiotherapy session

  3. Six minute walk test

    Validated functional outcome measure after total knee arthoplasty

    Measured: Measured once at the first postoperative visit with the surgeon, 6 weeks postoperative

  4. Timed up and go

    Functional outcome measure

    Measured: Measured once on postoperative day 2 during the physiotherapy session

  5. WOMAC

    Western Ontario and McMaster University Osteoarthritis Index - functional outcome measure questionnaire

    Measured: Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months)

  6. LEFS

    Lower extremity functional scale - functional outcome questionnaire

    Measured: Baseline questionnaire given preoperatively, at first postoperative visit (6 weeks), and second postoperative visit (3 months)

  7. Incidence of motor block

    weakness in quadriceps from femoral nerve block can delay physiotherapy and cause falls

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 days

  8. Complications of femoral nerve block, local infiltration analgesia

    hematoma, infection, persistent neurological deficit 6 weeks postoperatively

    Measured: From date of randomization until the first postoperative visit at 6 weeks

  9. Inability to ambulate/falls

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 days

  10. Nausea

    Measured: Participants will be followed for the duration of hospital stay, an expected average of 4 days

  11. NRS for pain

    Assessing worst pain during physiotherapy, later dates to assess for the incidence of chronic pain

    Measured: The highest NRS will be assessed daily during the patient's physiotherapy session, as well as the highest NRS achieved at 2 weeks, 6 weeks, and 3 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2012 (estimated)
  2. Study startSep 2012
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01616836
Sponsor's protocol ID
011-2012
Acronym
OPRA
Status last verified
Apr 2016
First submitted
7 Jun 2012
Last updated
13 Apr 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing continuous FNB, single femoral nerve block and local infiltration analgesia in people with Total Knee Arthroplasty, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numeric Rating Scale for Pain (time frame: 09h00 on postoperative day 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01616836.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2016.

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